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Yilmaz 2010 (Continued) Random sequence generation (selection bias) Low risk Quote: “computerized randomization codes .. in blocks of six”. Pg 83 Comment: probably done. Allocation concealment (selection bias) Low risk Quote: “by a statistician who was not one of the investigators of this study”. “Code numbers were written on the injectors and. ..drawn up.. by a pharmacist who was not one of the investigators in this study”. Pg 83 Comment: adequate steps appear to have been taken to ensure that participants and investigators enrolling participants could not foresee assignment in advance of, or during enrolment Blinding of participants and personnel (performance bias) All outcomes Blinding of outcome assessment (detection bias) All outcomes Incomplete outcome data (attrition bias) All outcomes Low risk Participants/healthcare providers: Quote: “orally disintegrating Ondansetron tablets dissolved.. and identical looking placebo liquid”. “The subjects, parents, study personnel and other medical staff were blinded to which study drug was given”. Pg 83 Comment: the investigators appear to have used adequate measures to blind study participants and personnel from knowledge of which intervention a participant received Low risk Outcomes assessors & data analysts: Quote: “ identical looking”....“study personnel and other medical staff were blinded to which study drug was given”. Pg 83 Comment: adequate measures were taken to blind study personnel who were outcomes assessors High risk A flow chart tracked participants but some were not accounted for at several stages in the study. 109 subjects were randomized to ondansetron (55) and placebo (54) arms. Two participants in the placebo group were removed from the study after receiving IV rehydration and were admitted to hospital but were not included in the analysis Selective reporting (reporting bias) Low risk No evidence of selective reporting of data and outcomes listed in the methods section were comparable to the reported results Antiemetics for reducing vomiting related to acute gastroenteritis in children and adolescents (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 42
Yilmaz 2010 (Continued) Other bias Low risk The report appeared to be free of other sources of bias. IQR: ORT: oral rehydration therapy Characteristics of excluded studies [ordered by study ID] Study Reason for exclusion Ginsburg 1980 Non RCT. Van Eygen 1979 No outcomes matching those specified in the protocol of this review RCT Characteristics of studies awaiting assessment [ordered by study ID] Debray 1990 Methods From translation: multi centre (5 hospitals), double blind, randomized study. Blinded data entry Participants 47 infants, no drop-outs. Only 49% with vomiting related to gastroenteritis Interventions 23 to alizapride, 24 to metopimazine (oral drops). Outcomes Time to cessation of vomiting sorted by 1-2 days, 2-3 days, 3-4 days Notes No separate data for participants with gastroenteritis-related vomiting Reeves 2002 Methods Quote: “A randomized, double blind, placebo-controlled trial, conducted in the emergency department of a tertiarycare children’s hospital” (Boston USA). “A computer randomization code was produced by a member of the medical school’s center for clinical investigation. Blocking was used in groups of 4, 6 or 10 as generated randomly by computer”. “All providers except the pharmacist were blinded to group assignment until after data analysis. The study investigators remained blinded until after complete statistical analysis was performed” Participants 107 children enrolled, 2 losses to follow-up, age range 3 months to 22 yrs Antiemetics for reducing vomiting related to acute gastroenteritis in children and adolescents (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 43
Page 1 and 2: Antiemetics for reducing vomiting r
Page 3 and 4: [Intervention Review] Antiemetics f
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Page 7 and 8: GRADEWorkingGroupgradesofevidence.
Page 9 and 10: Why it is important to do this revi
Page 11 and 12: confidence intervals (CI) and P val
Page 13 and 14: Figure 1. Study flow diagram (PRISM
Page 15 and 16: participants in Freedman 2006 and R
Page 17 and 18: Figure 3. Risk of bias summary: rev
Page 19 and 20: All of the studies with the excepti
Page 21 and 22: esults were similar and the conclus
Page 23 and 24: Primary outcomes Time taken from th
Page 25 and 26: D I S C U S S I O N Overall complet
Page 27 and 28: severity of disease; and on outcome
Page 29 and 30: and Adolescent Medicine 2003;157(5)
Page 31 and 32: Cubeddu 1997 (Continued) Risk of bi
Page 33 and 34: Freedman 2006 (Continued) dependent
Page 35 and 36: Ramsook 2002 (Continued) Bias Autho
Page 37 and 38: Roslund 2008 (Continued) Notes Quot
Page 39 and 40: Stork 2006 (Continued) REHYDRATION
Page 41 and 42: Uhlig 2009 (Continued) Intervention
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Page 47 and 48: NCT01165866 (Continued) Participant
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Page 63 and 64: A P P E N D I C E S Appendix 1. Sea
Page 65 and 66: Appendix 3. CENTRAL search strategy
Page 67 and 68: 48. exp child/ or child$.tw. 49. ex
Page 69 and 70: or hexadecadrol or hexadrol or loka
Page 71 and 72: 51. (promethazine or Avomine or adg
Page 73 and 74: W H A T ’ S N E W Last assessed a
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